Certifications | Quality Management Systems
QMSR
21 CFR 820, previously the Quality System Regulation and now the QMSR (Quality Management System Regulation) was made effective on February 2, 2026, and applies to companies in the USA and abroad, marketing and distributing medical device products (including many digital health and mobile apps) in the USA. Over the past few years, FDA has stepped up its inspection program for manufacturers resulting in more FDA-483 Inspection Observations, and, more often than not, in Warning Letters if not responded to in a timely and comprehensive manner. CRO Group offers a broad range of services to match your QMSR need – from establishing a transition plan, to training, to internal and or supplier audits, to computer system (Part 11) validations, and design control support.
To obtain a quote for CRO Group’s QMSR related services click here.
ISO 13485:2016
ISO 13485:2016 is the current International Standard for quality management systems for medical device developers, manufacturers and distributors as well as support organizations such as biomedical engineering service and installation companies. It is recognized and is often required for higher risk medical devices in most countries and regions such as the USA, Canada, the EU, Japan, and Australia. Certification to the standard is required for CE Marking for EU Class I-M, I-S, I-R, IIA, IIB, and III medical devices, Class B-D IVDs , and Canadian Class II through IV product licensing. There is also a growing demand for manufacturer support organizations to maintain registration as part of their relationship with the manufacturers who use them for local service, installation, training, etc. The CRO Group specializes in turnkey ISO 13485 preparation leading to registration as well as support in maintaining registration. To obtain a quote for ISO 13485 services, click here
EU MDR and IVDR
CE Marking requires quality systems certification for most medical device manufacturers. Depending on the applicable regulation (MDR or IVDR) and product risk, the manufacturer may need to draw up and submit technical documentation for review by a Notified Body for the product family as a critical part of meeting CE Marking requirements. The European QMS requirements coincide with those in the ISO 13485:2016 standard, but also include many “extras” – including for example, a procedure/process for updating the Risk Management files, filing and submitting Vigilance Reports, conducting Field Actions, Issuing Advisory Notices, and submitting Post Market Surveillance and PSUR reports. In addition, time is running out for companies which haven’t changed the devices and are still under the Transitional provisions. This all makes now an excellent time to plan and implement your company’s MDR/IVDR compliance process.
For a quote on CRO Group CE Marking and MDR/IVDR consulting services, click here.
MDSAP
MDSAP (Medical Device Single Audit Program) is the QMS scheme required for many medical device manufacturers marketing their products in Canada. MDSAP Certification, by a MDSAP recognized Auditing Organization (AO) is required for product licensing. Health Canada “adds” to the ISO 13485 requirements (for example, implant registration cards when on the CMDR list). MDSAP AO’s are required to examine manufacturer’s ability to conform to the additional requirements as a criteria for issuing the ISO 13485/MDSAP audit report. Successful MDSAP Certification can also reduce your FDA regular Inspection frequency (not including for-cause, follow-up or pre- or post-PMA approval). Australia, Brazil, and Japan all are participating in MDSAP and a successful MDSAP audit by a recognized AO can eliminate or reduce the QMS inspection requirements for that country.
For a quote on CRO Group’s MDSAP consulting services, click here